Ainulkhir H, Fredolin L, Noor Azlan M A, Ahneez A H, Nazlina I, Muhammad Ashraf S
Pathology Department, Queen Elizabeth Hospital, 88596 Kota Kinabalu, Sabah, Malaysia.
School of Biosciences and Biotechnology, Faculty of Science and Technology, Universiti Kebangsaan Malaysia (UKM), Bangi, 43600 Selangor, Malaysia.
Trop Biomed. 2018 Jun 1;35(2):511-520.
Accurate and timely diagnosis is critical for dengue patient management due to no specific treatment is available for the disease. The use of rapid diagnostic tests (RDTs) could assist in disease screening because of their simplicity and inexpensiveness but nonetheless, the performance of these tests needs to be carefully evaluated. Here, we report the performance of RVR Dengue Combo NS1-IgG/IgM Rapid Test for detection of dengue NS1 antigen and dengue-specific IgM using 98 samples that were screened initially using Panbio Dengue IgM Capture ELISA and Panbio Dengue Early Rapid Test. The positive percent agreement (PPA) between RVR Dengue Combo NS1-IgG/IgM Rapid Test and the reference comparator tests was 77.8% and negative percent agreement (NPA) was 95.7% for NS1 (κ=0.748, P<0.001). As for IgM, the PPA and NPA was 54.5% and 100.0% respectively (κ=0.561, P<0.001). Combining both NS1 and IgM results using a logical OR operator gave the best compromised PPA and NPA of 75.0% and 97.2% respectively (κ=0.743, P<0.001). In another aspect, all dengue negative samples with high titer of rheumatoid factor (RF) and Hepatitis B surface Antigen (HBsAg) were tested negative for NS1, IgG and IgM using this RDT thus indicating no cross-reactivity to these interference factors.
由于登革热没有特效治疗方法,准确及时的诊断对于登革热患者的管理至关重要。快速诊断检测(RDT)因其操作简便且成本低廉,可辅助疾病筛查,但这些检测的性能仍需仔细评估。在此,我们报告了RVR登革热组合NS1-IgG/IgM快速检测法在检测登革热NS1抗原和登革热特异性IgM方面的性能,该检测使用了98份最初通过Panbio登革热IgM捕获ELISA和Panbio登革热早期快速检测法进行筛查的样本。RVR登革热组合NS1-IgG/IgM快速检测法与参考对照检测法之间,NS1的阳性百分一致性(PPA)为77.8%,阴性百分一致性(NPA)为95.7%(κ=0.748,P<0.001)。对于IgM,PPA和NPA分别为54.5%和100.0%(κ=0.561, P<0.001)。使用逻辑或运算符结合NS1和IgM的结果,得到的最佳折衷PPA和NPA分别为75.0%和97.2%(κ=0.743,P<0.001)。另一方面,所有类风湿因子(RF)和乙肝表面抗原(HBsAg)高滴度的登革热阴性样本,使用该快速诊断检测法检测NS1、IgG和IgM均为阴性,这表明该检测法与这些干扰因素无交叉反应。